MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 6X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4156040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82220481 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 6x4 80cm powerflex extreme percutaneous transluminal angioplasty (pta) dilation catheter ruptured upon initial inflation at 6 atm.The procedure was completed with another 6x4 80cm powerflex extreme pta catheter.There was no reported patient injury.The device was prepped per the instructions for use (ifu) and delivered to the target lesion in the cephalic vein without issue.The target lesion had 80% focal stenosis.The device will not be returned for evaluation as it was previously discarded.
Additional Manufacturer Narrative
H10 as reported, the balloon of a 6x4 80cm powerflex extreme percutaneous transluminal angioplasty (pta) dilation catheter ruptured upon initial inflation at six atm.The procedure was completed with another 6x4 80cm powerflex extreme pta catheter.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu) and delivered to the target lesion in the cephalic vein without issue.The device prepped without difficulty and maintained negative pressure.There was no difficulty removing the product from the hoop or protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The target lesion had 80% focal stenosis, was moderately calcified, and had little tortuosity.The burst occurred in the middle section of the balloon, and the leak was noticed during use and confirmed ruptured upon removal.The contrast to saline ratio was 50/50.And a non-cordis indeflator was used and was previously used successfully with other devices.No resistance or friction was noted while inserting the balloon through the rotating hemostatic valve, through the guide catheter, or through the vessel.There was no difficulty crossing the lesion and the catheter was never in an acute bend.The balloon catheter did not kink while being used.The product was removed intact from the patient.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 82220481 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors likely contributed to the reported event as the lesion was described as having 80% focal stenosis, moderate calcification and little tortuosity.Therefore, with the information available and without return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event.According to the safety information in the instructions for use ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in-vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: POWERFLEX EXTREME 6X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13060350
• Report Number: 3009018440-2021-00004
• Device Sequence Number: 19208916
• Product Code: LIT
• UDI-Device Identifier: 20705032001752
• UDI-Public: (01)20705032001752(17)240331(10)82220481
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 4156040S
• Device Catalogue Number: 4156040S
• Device Lot Number: 82220481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown